RT Journal Article SR Electronic T1 Risk Assessment Approach to Microbiological Controls of Cell Therapies JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 229 OP 248 DO 10.5731/pdajpst.2019.010546 VO 74 IS 2 A1 Tony Cundell A1 Scott Drummond A1 Irving Ford A1 Dona Reber A1 Donald Singer A1 , YR 2020 UL http://journal.pda.org/content/74/2/229.abstract AB This technology review, written by a small group of pharmaceutical microbiologists experienced in cell therapies, discussed a risk-based approach to microbiological contamination detection and control during gene and cell therapy production. Topics discussed include a brief overview of cell therapies, a risk analysis related to donor selection, cell collection and infectious agent testing, cell transformation and expansion, packaging, storage, and administration, and cell therapy microbial contamination testing and release.